[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-leukemia":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,58,87,123,158,200],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":39,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255",false,"NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","ALL","3 Years","39 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[28,29,30,31,32,33,34,35,36,37,38],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia","B-precursor ALL","B-All","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia","Acute Lymphoid Leukemia",[40,41,42,43,44,33,32,31,30,29],"Philadelphia chromosome + ALL","Lymphoma","CD-22 Expressing Tumor","CD-19 expressing tumor","Adoptive Immunotherapy","RECRUITING","2026-06-30",{"date":48,"type":49},"2026-07-01","ACTUAL",{"date":51,"type":49},"2022-12-28",{"date":53,"type":21},"2029-07-01",{"name":55,"class":56},"National Cancer Institute (NCI)","NIH",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":57},"100363739","phase-1-car-t-immunotherapy-targeting-cd19--all-100363739","NCT04016129","CAR-T Immunotherapy Targeting CD19- ALL","CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.\n3. Malignant B cells expressing one or more of the following surface molecules: CD22\u002FCD123\u002FCD38\u002FCD10\u002FCD20\u002FTSLPR.\n4. The KPS score over 80 points, and survival time is more than 1 month.\n5. Greater than Hgb 80 g\u002FL.\n6. No contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. Complications with other active diseases, and difficult to assess patient response.\n2. Bacteria, fungus, or virus infection, and unable to control.\n3. Living with HIV.\n4. Active HBV and HCV infection.\n5. Pregnant and nursing mothers.\n6. Under systemic steroid use within a week of the treatment.","6 Months","75 Years",{"count":68,"type":21},100,[24,25],"This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I\u002FII trial enrolling patients from multiple clinical centers.",[72],"B-cell Leukemia",[74,75,76],"CD19- B-ALL","CART","CD22, CD123, CD38, CD10, CD20, TSLPR","2026-06-18",{"date":79,"type":49},"2026-06-23",{"date":81,"type":49},"2025-07-15",{"date":83,"type":21},"2029-12-15",{"name":85,"class":86},"Shenzhen Geno-Immune Medical Institute","OTHER",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":107,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100532125","phase-1-clic-2201-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100532125","NCT06208735","CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria in Cohort A:\n\nParticipants must meet the following criteria to be enrolled on the trial:\n\n1. Participants in the cohort A must be 18 years of age or older of age at time of informed consent.\n2. Participants must provide written informed consent.\n3. Participants must have a relapsed or refractory B cell lymphoma, including one of the following:\n\n   1. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),\n   2. high grade B cell lymphoma NOS,\n   3. high grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements,\n   4. primary mediastinal large B-cell lymphoma (PMBCL),\n   5. aggressive B cell lymphoma transformed from an indolent lymphoma,\n   6. mantle cell lymphoma (MCL),\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥40%,\n   2. Creatinine clearance using Cockcroft-Gault of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n6. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.\n7. Females of child-bearing potential and sexually active males must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n8. Participants with accessible disease, must be willing to undergo a tumour biopsy at enrolment. For participants with a recent (within 3 months) tumor biopsy, access to the archival biopsy is acceptable.\n\nInclusion Criteria in Cohort B:\n\n1. Participants in the cohort B must be between 1-39 years of age at the time of consent.\n2. For participants who are under the age of consent as defined by REB requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent\u002Fconsent must be obtained (if applicable).\n3. Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants in cohort B and\u002For those who have received CD22 targeted therapy must have documentation of CD22 tumour expression within the 6 months prior to study screening, and after any prior CD22 directed therapy (if applicable).\n6. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥45%,\n   2. Creatinine clearance using Cockcroft-Gault or Schwartz equation of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n7. Participants must have a Karnofsky or Lansky Score ≥50%.\n8. Participants of reproductive age must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n9. Participants must be willing to undergo a bone marrow biopsy at enrolment.\n\nExclusion Criteria:\n\n1. Any uncontrolled or serious active infection at the time of enrolment.\n2. Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.\n3. Live vaccine ≤6 weeks prior to enrolment\n4. Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.\n5. Diagnosis of primary central nervous system lymphoma (PCNSL)\n6. Treatment with any of the following in the specified time period before leukapheresis:\n\n   1. Allogeneic HCT within 3 months,\n   2. Autologous HCT within 3 months,\n   3. CD19 CAR-T cell infusion within 3 months,\n   4. Donor lymphocyte infusion (DLI) within 3 months,\n   5. Bendamustine within the last 6 months,\n   6. Any investigational agent within 30 days or 5 half-lives (whichever is shorter),\n   7. Systemic administration of therapeutic dose corticosteroids (\\>20 mg\u002Fday prednisone or equivalent for adults and ≥ 12 mg\u002Fm2\u002Fday for paediatric participants) within 7 days prior to leukapheresis.\n   8. Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks, unless used as treatment for the B cell malignancy.\n   9. Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.\n7. Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n8. Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.\n9. Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.\n10. Any Human Immunodeficiency Virus (HIV) infection at time of screening.\n11. Hypersensitivity to fludarabine or cyclophosphamide.\n12. Any allergy to gentamycin or its derivatives\n13. Participants who do not meet the minimum weight requirement for the planned dose level.\n14. Pregnant or nursing participants.","1 Year",{"count":96,"type":21},24,[24],"This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed\u002Frefractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion.\n\nThe primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies.\n\nThe secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201.\n\nExploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.",[37,100,101,102,103,104,105,106],"Non-Hodgkin's Lymphoma","B-cell Acute Lymphoblastic Leukemia","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Mantle Cell Lymphoma","B-cell Lymphoma",[108,109,110,111,112],"Chimeric Antigen Receptor T cells","CLIC-2201","CD22","Immunotherapy","CAR-T cell","2026-03-30",{"date":115,"type":49},"2026-04-03",{"date":117,"type":49},"2025-01-02",{"date":119,"type":21},"2027-08-01",{"name":121,"class":86},"British Columbia Cancer Agency",7,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":143,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100625415","a-multi-site-study-to-evaluate-the-persistence-of-protective-immunity-to-routine-childhood-vaccinations-in-participants-with-b-allly-who-have-received-blinatumomab-100625415","NCT07422337","A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL\u002FLy Who Have Received Blinatumomab","Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination","BOOSTER","Inclusion Criteria:\n\n* Diagnosis of B-lineage acute lymphoblastic leukemia\u002Flymphoma\n* ≥1 year old and up to 21 years old at diagnosis\n* Informed consent provided, and if applicable, child assent provided\n* Must have received all vaccinations routinely administered during first year of life\n\nExclusion Criteria:\n\n* Relapsed\u002Frefractory disease at any time\n* Received or will require a bone marrow transplant and\u002For cellular therapy\n* Pregnancy","23 Years",{"count":133,"type":21},300,"OBSERVATIONAL","The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia\u002FLymphoma. The main study aims are:\n\n* Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL\u002FLy who have received blinatumomab.\n* To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity.\n\nResearchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.",[137,138,139,140,141,101,142,72],"B-Cell ALL","B-Cell Acute Lymphoblastic Leukaemia","B-Cell Lymphoblastic Leukemia","B-Cell Lymphoblastic Leukemia\u002FLymphoma","B-cell Acute Lymphoblastic Leukemia (B-ALL)","B-cell Childhood Acute Lymphoblastic Leukemia",[144,145,146,147],"vaccines","cancer","blinatumomab","immunotherapy","2026-02-23",{"date":150,"type":49},"2026-02-25",{"date":152,"type":49},"2026-01-13",{"date":154,"type":21},"2029-01",{"name":156,"class":86},"Arkansas Children's Hospital Research Institute",2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":57},"100605748","phase-1-bispecific-car-t-cells-for-b-cell-malignancies-basecar-01-trial-100605748","NCT07166549","Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)","A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies","BaseCAR-01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including:\n\n  * Acute B-lymphoblastic leukaemia\n  * Burkitt lymphoma\n  * Primary CNS lymphoma\n  * DLBCL or high-grade lymphoma of any subtype\n  * Primary mediastinal B cell lymphoma (including grey zone lymphoma)\n  * Mantle Cell lymphoma\n  * Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)\u002F small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma\u002Fleukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma\n* CD19 and\u002For CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)\n* ECOG clinical performance status ≤2\n* Able to provide written informed consent.\n* Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as:\n\n  * Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed)\n  * Adequate renal function: creatinine clearance ≥30 mL\u002Fmin\u002F1.73 m2\n  * Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \\> 91% with room air.\n  * Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia\n  * Adequate bone marrow reserve (Hemoglobin ≥80 g\u002FL (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\\^9\u002FL (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\\^9\u002FL (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10\\^9\u002FL)\n* Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy.\n\nExclusion Criteria:\n\n* Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs\n* Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.\n* Uncontrolled coronary artery disease or uncontrolled arrhythmias\n* Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.\n* Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).\n* Active secondary malignancy that progressed or required treatment in the last 24 months, other than basal or squamous cell carcinomas of the skin. Further allowed exceptions are: Non-muscle-invasive bladder cancer, non-invasive cervical cancer, or other malignancy that is considered cured or to have a minimal risk of recurrence (e.g. a history of localized prostate or localized and treated breast cancer).\n* Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection.\n* Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide\n* Cytotoxic chemotherapy within 14 days before apheresis collection for CAR-T cells, respectively 12 weeks for Bendamustin and Fludarabine, and 6 months for Alemtuzumab and ATG.\n* Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion.\n* Patients who have undergone allogeneic hematopoietic stem cell transplantation less than 12 weeks ago, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n* Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion.\n* Investigational treatments within other trials ≤ 4 weeks before enrollment.\n* Lack of safe contraception; Women who are pregnant or breastfeeding; and men who plan to father a child while enrolled in this study within 1 year of receiving bispecific anti-CD20, anti-CD19 CAR T cells.","18 Years",{"count":168,"type":21},12,[24],"This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma\u002Fleukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.",[172,72,173,174,175],"B Cell Malignancies","B Cell Lymphoma","Bispecific Chimeric Antigen Receptor (CAR) T Cells","Relapsed or Refractory (r\u002Fr) B-cell Malignancies",[177,178,179,180,181,182,183,184,185,186,187,188,189],"Bispecific anti-CD19, anti-CD20 CAR T cell therapy","lymphapheresis","lymphodepleting (non- myeloablative) chemotherapy","Immune effector cell-associated neurotoxicity syndrome (ICANS)","Cytokine release syndrome (CRS)","Immune effector cell-associated haematotoxicity (ICAHT)","European Group for Blood and Marrow Transplantation (EBMT)","18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)","positron emission computed tomography (PET CT)","acute lymphocytic leukemia (ALL)","immunoglobulin heavy chain (IGH)","non-Hodgkin's lymphoma (NHL)","Eastern Cooperative Oncology Group (ECOG)","NOT_YET_RECRUITING","2025-12-17",{"date":193,"type":49},"2025-12-24",{"date":195,"type":21},"2026-06",{"date":197,"type":21},"2028-11",{"name":199,"class":86},"University Hospital, Basel, Switzerland",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":211,"conditions":212,"keywords":219,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":57},"100499182","early-phase-1-safety-and-feasibility-of-cd19-car-t-cells-using-clinimacs-prodigy-for-relapsedrefractory-cd19-positive-all-and-nhl-100499182","NCT05779930","Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed\u002FRefractory CD19 Positive ALL and NHL","Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed\u002FRefractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma","Eligible Diseases:\n\nRelapsed or refractory pediatric B-Cell ALL as defined by at least one of the following criteria:\n\n* Second or greater relapse OR\n* Any relapse after allogeneic SCT OR\n* Not achieving a CR after 2 cycles of standard chemotherapy regimen (including persistent MRD positive disease) OR\n* Not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia (including persistent MRD positive disease) OR\n* Patients with Philadelphia chromosome positive (Ph+) ALL who are intolerant or have failed 3 lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy is contraindicated OR\n* Patients who meet accepted indications for allogeneic HSCT for pediatric ALL but are deemed unfit for HSCT by their treating physician are eligible for this study. This includes high risk patients in first relapse.\n\nPatients with relapsed or refractory pediatric B cell non-Hodgkin's Lymphoma as defined by:\n\n* Refractory to second-line or later lines of standard chemotherapy OR\n* Patients with residual disease after primary therapy and not eligible for autologous SCT OR\n* Any relapse after previous allogeneic or autologous SCT OR\n* Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT\n\nNote: patients with a history of blinatumomab therapy are eligible for this study.\n\nInclusion Criteria:\n\n* For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry at most recent relapse or reconfirmed after CD19 directed therapy in ALL patients. For patients with NHL, documentation of CD19 positivity must be available from biopsy at diagnosis or most recent tumor biopsy.\n* Age 0 to age 30 at the time of initial diagnosis. Note: the first three subjects enrolled must be ≥16 years of age\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are eligible if there is documented evidence of disease stabilization for at least 1 month prior to CD19 CAR T cell infusion.\n* Meets criteria for non-hematopoietic organ function:\n\n  * Renal function: Estimated glomerular filtration rate ≥60 mL\u002Fmin x appropriate estimation of patient's body surface area m2\u002F1.73m2 using the modified Schwartz formula for pediatric patients and Crockcoft Gault formula for adults.\n  * Liver function: Total bilirubin ≤ 2 mg\u002Fdl or ≤ 2.5 x ULN for age (unless Gilbert's syndrome) and ALT and AST ≤ 5 x ULN for age (unless related to leukemic involvement)\n  * Cardiac function: left ventricular ejection fraction ≥40%\n  * Pulmonary function: minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\>91% on room air\n* Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator.\n* Signed consent by parent\u002Fguardian and assent if appropriate for subjects \\\u003C 18 years of age. Signed consent by patient\u002Fsubject if ≥18 years of age.\n\nExclusion Criteria:\n\n* Acute\u002Fongoing neurologic toxicity \\> Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable\u002Fimproving over the past 1 months.\n* Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.\n* Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment\n* Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening\n* Pregnant or nursing (lactating) women.\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* HIV positive test within 8 weeks of screening\n* Allogeneic HSCT within 3 months of enrollment\n* Any prior CD19 CAR T cell therapy","30 Years",{"count":168,"type":21},[210],"EARLY_PHASE1","This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.\n\nPatients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.",[213,214,215,216,217,218],"Acute Lymphoblastic Leukemia, in Relapse","Non-Hodgkin's Lymphoma, Relapsed","Non-Hodgkin's Lymphoma Refractory","Acute Lymphoblastic Leukemia With Failed Remission","B-cell Non Hodgkin Lymphoma","B Cell Leukemia",[16,220,221],"NHL","CD19 CAR T cells","2025-08-13",{"date":224,"type":49},"2025-08-15",{"date":226,"type":21},"2025-10",{"date":228,"type":21},"2035-12",{"name":230,"class":86},"Nationwide Children's Hospital"]